BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB TOUGH STRIPS 20S USA

    MDR report key: 7699336 · Received July 18, 2018

    Report

    Report Number
    8041154-2018-00009
    Event Type
    Injury
    Date Received
    July 18, 2018
    Report Date
    July 19, 2018
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE MANUFACTURE DATE: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON (B)(6) 2016. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. (B)(4). LOT NUMBER = (10)0086B. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: GABAPENTINE; 300 2X DAY; YEARS; PAIN; CONSUMER STILL ON DRUG. DRUG: HYDROCODONE; 725-325; YEARS; PAIN; CONSUMER STILL ON DRUG. DRUG: NORCO; UNKNOWN; YEARS; PAIN; CONSUMER STILL ON DRUG. DRUG: PAMELOR (GENERIC); 25 MG 1X NIGHT; YEARS; MUSCLE RELAXER; CONSUMER STILL ON DRUG. DRUG: TIZANIDINE; 4 MG 1X DAY; YEARS; MUSCLE RELAXER; CONSUMER STILL ON DRUG. DRUG: ESTRADIOL; 2 MG 1X BED TIME; YEARS; ESTROGEN; CONSUMER STILL ON DRUG. DRUG: MULTIVITAMINS; DAILY; YEARS; SUPPLEMENTS; CONSUMER STILL ON DRUG. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A (B)(6) FEMALE CONSUMER REPORTED THAT SHE USED A TOUGH STRIP BAND AID AND HER ARM. SHE HAD IT ON FOR OVER 24 HOURS. WHEN SHE REMOVED IT, HER SKIN STUCK TO THE BAND AID AND TORE HER SKIN OFF THE WHOLE LENGTH OF THE BAND AID. SHE COULD NOT GET THE WOUND TO STOP BLEEDING AND 2 DAYS LATER SHE WAS TREATED AT THE EMERGENCY ROOM. THIS HAPPENED ABOUT 3 MONTHS AGO AND THE CONSUMER STATED THAT THE EVENT IS HEALED, BUT SHE HAS A SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540602 BAB TOUGH STRIPS 20S USA ADHESIVE BANDAGE KGX JOHNSON & JOHNSON CONSUMER INC 381370044086 0086B

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention ESTRADIOL| GABAPENTINE| HYDRCODONE| MULTIVITAMINS| NORCO| PAMELOR (GENERIC)| TIZANIDINE| ESTRADIOL| GABAPENTINE| HYDRCODONE| MULTIVITAMINS| NORCO| PAMELOR (GENERIC)| TIZANIDINE